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Post by dreamboatcruise on Feb 3, 2016 18:38:48 GMT -5
Bankruptcy note. Matt said it would be last resort but that no plans for it. My read on that "no plans" for it is he hopes that negotiation with lenders etc will help buy time but what if those lenders wish not to change the current terms? That BK as last resort is going to come into focus pretty quickly. I know some on here thing the call went well but I do not. Not at all because Matt allowed uncertainty to become a large part of the call. It's why the AH price is tanking and why tomorrow has the makings of a very bad day for the stock. Pish, posh... "nothing to see here" "move along, you didn't hear BK" |
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Post by BlueCat on Feb 3, 2016 18:39:04 GMT -5
I think it was a clear positive that they have reopened discussions with regions/countries for distributing Afrezza where FDA approvals will suffice to meet pharmaceutical regulatory requirements. The question is, can they legally even have such discussions as long as SNY holds the rights? One would think that with SNY having given notice, MNKD would be free to discuss actions which would not have an effective date until after the transfer. The restriction on talks seems to have to do with "return of NDA". The NDA is an FDA thing. I would assume that any restrictions would only apply to FDA jurisdiction... i.e. U.S. But it sure would have been nice for them to state exactly what they can and cannot do... or more specifically can do, rather than simply the complete or partial "can't" list. Maybe in their FAQ they could build a nice chart title "What We Can or Cannot Do Before April 5 or Later NDA Return" with check boxes in columns marked "Yes", "No" and "partial". With rows like, "can you engage partners outside of US for distribution?" "Can you engage a third-party to engage with payors?" And so forth. Oy. |
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Post by esstan2001 on Feb 3, 2016 18:40:06 GMT -5
I think it was a clear positive that they have reopened discussions with regions/countries for distributing Afrezza where FDA approvals will suffice to meet pharmaceutical regulatory requirements. The question is, can they legally even have such discussions as long as SNY holds the rights? One would think that with SNY having given notice, MNKD would be free to discuss actions which would not have an effective date until after the transfer. I think they can enter into NDA's to talk about what they would do and propose the structure of a deal for once the rights are returned- just nothing contractual until they own the right |
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Post by cjc04 on Feb 3, 2016 18:42:18 GMT -5
Thought a pilot in Jersey was schedule to start this month (Feb). Looks like that got bumped back. Horrible call overall. We would have been significantly better off with no update. Basically a rehash of the JPM conference - except that bankruptcy was mentioned umpteen times and described as "not a possibility at this time" which is verbatim what they said about SNY splitting. Also, confirmed that absolutely nothing is going to happen with afrezza until April other than the afrezza clinics. And we'll probably take another hammering on the quarterly earnings call. They most likely just sunk us back to .50. I agree, horrible!!! Didn't feel like a call for investors, felt more like a desperate sales job looking, begging for a partner for anything. I feel the same way about his answers on BK that I felt about his answers on SNY splitting. As for SNY returning Afrezza, I just don't get it. SNY might as well be a competitor RIGHT NOW! Yet they have total control as they walk out the door. How the hell can we have put ourselves in such a helpless position. I can only PRAY that this is some sort of negotiation period where SNY ends up the buyer. My God! Looking back at the last 2 years you'd think MNKD was out to destroy themselves. |
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Post by peppy on Feb 3, 2016 18:43:19 GMT -5
are Mannkinds hands completely tied?
they will not get afrezza back until april 5th.
Hands tied until april 5th?
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Post by dreamboatcruise on Feb 3, 2016 18:46:56 GMT -5
I think it was a clear positive that they have reopened discussions with regions/countries for distributing Afrezza where FDA approvals will suffice to meet pharmaceutical regulatory requirements. The question is, can they legally even have such discussions as long as SNY holds the rights? One would think that with SNY having given notice, MNKD would be free to discuss actions which would not have an effective date until after the transfer. I think they can enter into NDA's to talk about what they would do and propose the structure of a deal for once the rights are returned- just nothing contractual until they own the right You probably know this, but just to avoid confusion for others... you are talking about a Non-disclosure Agreement whereas the NDA that Matt was talking about being "returned" is the New Drug Application. Apparently, when SNY took over Afrezza there was some formal process whereby they took over the NDA that MNKD had previously filed and thus SNY has certain legal roll that MNKD cannot now step into without another hand off (my reading between the lines). |
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Post by dudley on Feb 3, 2016 18:50:02 GMT -5
I think it was a clear positive that they have reopened discussions with regions/countries for distributing Afrezza where FDA approvals will suffice to meet pharmaceutical regulatory requirements. The question is, can they legally even have such discussions as long as SNY holds the rights? One would think that with SNY having given notice, MNKD would be free to discuss actions which would not have an effective date until after the transfer. Hi Chris - Matt clearly stated they CAN have discussions - (from the JPM conference transcript : "We will -- we have been developing a new marketing and sales strategy at the same time now that we are somewhat unshackled from Sanofi, we can go back and pursue partnership. So we weren’t able to talk to anybody about that while still partnered with Sanofi, but that's now gone away. So we have reinitiated those discussions.") So they could have all the ground work laid, contracts drawn up etc. before the handoff and hit the ground running the next day. I would guess they could announce it once a deal was signed even if it was not effective until April 5th - or possibly later. My guess is it probably WILL run a bit past the April 5th date just because almost NOTHING ever happens precisely on time with things like this. Currently Sanofi has EXCLUSIVE rights to all marketing and distribution so that means nobody else can do squat as far as actually marketing and moving Afrezza. As to the care centers I would assume they can prescribe Afrezza and deal with the patient assistance without violating any Sanofi rights - just as a doctor can prescribe and help patients with titration etc. |
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Post by agedhippie on Feb 3, 2016 18:52:33 GMT -5
are Mannkinds hands completely tied? they will not get afrezza back until april 5th. Hands tied until april 5th? Until April 5th at the earliest, but Mannkind may request an extension. Afrezza is not covering it's costs and while the agreement remains in place Sanofi picks up 65% of the costs and loans Mannkind the remaining 35%. For that reason I would want to defer the exit as long as possible while I set up 2.0 |
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Post by cjc04 on Feb 3, 2016 18:52:46 GMT -5
Bankruptcy note. Matt said it would be last resort but that no plans for it. My read on that "no plans" for it is he hopes that negotiation with lenders etc will help buy time but what if those lenders wish not to change the current terms? That BK as last resort is going to come into focus pretty quickly. I know some on here thing the call went well but I do not. Not at all because Matt allowed uncertainty to become a large part of the call. It's why the AH price is tanking and why tomorrow has the makings of a very bad day for the stock. Shall we use the negotiations on the Aug debt as an example? That went well..... |
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Post by factspls88 on Feb 3, 2016 19:02:23 GMT -5
Anyone hear Matt is not taking increase in pay? Thats very admirable Yes, it's going to be rough living on an annual salary of $839,000 (according to profile section of Yahoo). Supreme sacrifice. |
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Post by centralcoastinvestor on Feb 3, 2016 19:04:07 GMT -5
are Mannkinds hands completely tied? they will not get afrezza back until april 5th. Hands tied until april 5th? Until April 5th at the earliest, but Mannkind may request an extension. Afrezza is not covering it's costs and while the agreement remains in place Sanofi picks up 65% of the costs and loans Mannkind the remaining 35%. For that reason I would want to defer the exit as long as possible while I set up 2.0 Good point. |
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Post by factspls88 on Feb 3, 2016 19:06:16 GMT -5
Yeah I didn't think there would be any regulations, since these are so called "Afrezza" clinics, I'm sure they wouldn't offer a competing prandial as an option but push for 'A all the way! And as for basal, I would hope that they bury lantus/toujeo with tresiba as the "preferred" option  The only thing is... I still don't see how the clinic manages to pay the staff. It would seem no insurer is going to put them in network, if they openly say they plan to prescribe something that the insurers don't won't to pay for. Fewer and fewer people are on insurance plans where they can go to whomever they wish. Good point. Afrezza needs to get on more formularies if this stands a chance of succeeding. Maybe that's why this isn't going to happen in February. |
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Post by dreamboatcruise on Feb 3, 2016 19:07:21 GMT -5
Until April 5th at the earliest, but Mannkind may request an extension. Afrezza is not covering it's costs and while the agreement remains in place Sanofi picks up 65% of the costs and loans Mannkind the remaining 35%. For that reason I would want to defer the exit as long as possible while I set up 2.0 Good point. But it seems there are too many restrictions. I have said exactly the same, but now knowing they can't talk to payers I can't imagine that the delay would be worth it. Talking to payers has to be near the top of what I would think would be their list of setting up 2.0. Also on the list would be talking to FDA about superiority trials... would they still really be trusting SNY to do that? |
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Post by joeypotsandpans on Feb 3, 2016 19:08:16 GMT -5
Good summary. The call was mostly positive and helpful. I find it interesting that the Shoutbox was so negative.The two main negative items: 1. TS pain is apparently on the backburner (though I'm not surprised because of cost) 2. MannKind isn't able to make changes to Afrezza pricing/marketing strategies until licensing transitions back to MannKind (this may take longer than expected). The main concern is obviously cash burn until Afrezza sales can be turned around. And, new partners and milestones payments aren't likely to show up for a while. The positive: MannKind remains committed to Afrezza/TS and Management no longer appears apathetic to shareholders. I think the company is moving in the right direction. The Stock is still a HOLD but I feal that the stock is undervalued here. If I had to pick a number I'd say MNKD is worth 3$, but I'm not buying until another partner steps forward. The first partner is likely an international Afrezza partner, but Sanofi needs to go away first.  . Other things that are not surprising, over the last few weeks I've encountered diabetics, family members of diabetics, phlebotomists, among others that still have no idea that this is available let alone been on the market for coming on a year now. I literally have had them ask me if they can take a picture of the dreamboat to bring to their physician, etc.
Anyone that thinks/claims SNY has any case whatsoever of a commercially reasonable effort to market Afrezza is FOS. Matt was pretty diplomatic in his description of his thoughts about that as well. When one of their (SNY) own reps is willing to make a change because they still believe this is a phenomenal product for diabetics, well like I said in a previous post, that speaks volumes. A few magazine ads, etc. does not cut the mustard for a revolutionary breakthrough product...label restrictions and all included. Personally, I would have loved to ask Matt what his and/or Al's thoughts were about the this www.aboutlawsuits.com/levaquin-rico-lawsuit-93357/ which has been brought up but shouldn't be taken lightly IMO. |
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Post by BlueCat on Feb 3, 2016 19:16:22 GMT -5
It is clear there is no love loss between Matt and SNY. I liked how he said "lessons learned" and left the subject immediately. Speaks volumes.
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. Other things that are not surprising, over the last few weeks I've encountered diabetics, family members of diabetics, phlebotomists, among others that still have no idea that this is available let alone been on the market for coming on a year now. I literally have had them ask me if they can take a picture of the dreamboat to bring to their physician, etc.